Amgen Ltd

Section 2 - QUALITATIVE AND QUANTITATIVE COMPOSITION

Updated to include information regarding the excipient sodium

Section 3 - PHARMACEUTICAL FORM

Inclusion of the text ‘Clear, colourless solution’

Section 4.2 - Posology and method of administration

Updated with minor formatting changes and addition of the sub-section ‘Method of administration’

Section 4.4 - Special warnings and precautions for use

Updated to include information regarding the excipient sodium

Section 4.5 - Interaction with other medicinal products and other forms of interaction

Updated with minor formatting changes and clarifications

Section 4.7 - Effects on ability to drive and use machines

Updated to state that ‘Aranesp has no or negligible influence on the ability to drive and use machines’.

Section 4.8 - Undesirable effects

Table heading revised from ‘Incidence of undesirable effects considered related to treatment with Aranesp from controlled clinical studies are:’ to ‘Incidence of adverse reactions from controlled clinical studies are:’

Section 5.1 - Pharmacodynamic properties

Clarification of the Pharmacotherapeutic group

Section 6.5 Nature and contents of container

Revision of the text describing nature and contents of containers

Section 6.6 Special precautions for disposal and other handling

Addition of ‘and other handling’ to the sub title and other minor changes

Section 10 - DATE OF REVISION OF THE TEXT

Date of revision changed from 20 December 2010 to 28 February 2011

In addition, there have been updates throughout the SPC to bring in line with SmPC Guideline Rev.2. 

For patients with Chronic Renal Failure the following sections of the Aranesp^® SPC have been updated to incorporate results from the clinical study “Trial to Reduce Cardiovascular Events with Aranesp^® Therapy”

·         4.4 “Special warnings and precautions for use”

·         4.8 “Undesirable effects” (this section includes the addition of stroke as a common adverse drug reaction in Chronic Renal Failure patients)

·         5.1 ‘Pharmacodynamic properties’ 

Section 4.4 “Special warnings and precautions for use” has been updated to add a warning to specify that cases of severe hypertension have been seen in Chronic Renal Failure patients treated with Aranesp^® therapy, including cases of hypertensive crisis, hypertensive encephalopathy and seizures.

Change to section 4.4 Special warnings and precautions for use

The SPC has been updated to provide guidance to physicians on ensuring appropriate identification and traceability of the product used.

Changes to section 4.8 Undesirable effects

To include hypertension as an undesirable effect identified in the post-marketing setting in patients.

To provide clarification that frequency cannot be estimated for undesirable effects identified in the post-marketing setting.

Change to section 10 Date of revision of the text

Change of date

In order to reflect the need for traceability of specific products ‘darbepoetin alfa’ and ‘Aranesp’ are referred to appropriately throughout the SPC.  The following sections have been updated: 

4.4 Special warnings and precautions for use

4.5 Interaction with other medicinal products and other forms of interaction

4.8 Undesirable effects

4.9 Overdose

5.3 Preclinical safety data

Extension of licence for paediatric patients